FDA inspection
Surgitools Pty Ltd: FDA inspection ending Apr 17, 2019
FDA inspection 1088097 · Voluntary Action Indicated (VAI) · Shanghai
Key facts
| Inspection ID | 1088097 |
|---|---|
| Firm | Surgitools Pty Ltd |
| FEI number | 3013521122 |
| Address | No 6 Hongan Road, Jinshan |
| City | Shanghai |
| Country | China |
| Fiscal year | 2019 |
| Inspection end date | Apr 17, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data